Unlike its predecessor, under which all novel foods were subject to the same rules, the new Novel Food Regulation 2015/2283 introduces the notion of ‘traditional foods from a third country’, and aims to facilitate their placing on the EU market, by laying down specific rules for them.
A traditional food from a third country is defined as “novel food [falling into some specific categories of novel food mentioned by the Regulation] which is derived from primary production (…) with a history of safe food use in a third country”.
Thus, it is, first and foremost, a novel food, i.e. not consumed within EU before 1997 and falling into one of the categories explicitly mentioned by the Regulation.
Notably, traditional foods are falling into at least one of the four following categories of novel foods: food consisting of, isolated from or produced from:
- microorganisms, fungi or algae;
- plants of their parts; and
- animals and their parts or cell culture of tissue culture derived from animals, plants, micro-organisms, fungi or algae.
The other six categories of novel foods mentioned by the Regulation mainly refer to technological progress, and traditional foods are therefore by definition not falling in those categories.
Secondly, a traditional food should be derived from the primary production within the meaning of the definition laid down in the General Food Law Regulation 178/2002 , namely “the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter, hunting, fishing and the harvesting of wild products”.
Thirdly, and to finish, solid proofs of a history of safe use of the traditional food in at least one non-EU country have to be provided. This safety must have been confirmed with compositional data and from experience of continued used for at least twenty-five years in the customary diet of a significant number of people in at least one third country .
Simplified procedure of authorization
As every other novel food, a traditional food from a third country needs a premarket authorization to be sold as such, or used in foods within the European Union.
But articles 14 to 20 of Regulation 2015/2283, completed by Commission Implementing Regulation 2017/2468, specifying administrative and scientific requirements concerning traditional foods from third countries , introduces a special procedure for their safety assessment.
Instead of following the normal procedure for authorizing a novel food , a food business operator may opt to submit to the Commission a notification of his intention to place on the EU market a traditional food from a third country.
This notification must then be forwarded by the Commission to all Member States and EFSA, which may within four months submit duly reasoned safety objections to the placing on the market of the notified food.
In case of submission of any safety objection, the applicant may convert the notification into an application, for which a safety evaluation will be requested from EFSA. Otherwise, the traditional food will be directly authorized by the European Commission.
Total time length of this simplified procedure is intended to take between four to nine months at most, whereas the classical procedure can take nearly twice this time. In addition, the content of the dossier, even when converted in a genuine application, is reduced.
To date, after only three months of application of the new Novel Food Regulation, two notifications have already been communicated to the European Commission. The notifications regarded fonio (decorticated grains of a small seeded cereal, historically used in West-Africa as a substitute for rice) and haskap berries (consumed at least in Japan over past 25 years according to the applicant).
The way these notifications will be handled will be a real test – as it is likely to foreshadow the practice that will be developed by the authorities to rule on the efficiency of this totally new procedure.
This article was first published at EU Food Law on 1 Aug 2019